Review Pathway

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.

A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.